BIAFINE Topical Cream
K-Number: K190342 · 2019-10-18
ApplicantBausch Health Americas Incorporated
Decision Date2019-10-18
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
BIAFINE Topical Cream is a medical device manufactured by Bausch Health Americas Incorporated. It received FDA 510(k) clearance on 2019-10-18 under approval number K190342. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BIAFINE Topical Cream?
BIAFINE Topical Cream is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Bausch Health Americas Incorporated. The 510(k) number is K190342.
When was BIAFINE Topical Cream approved by the FDA?
BIAFINE Topical Cream received FDA 510(k) clearance on 2019-10-18, under approval number K190342.
What company makes BIAFINE Topical Cream?
BIAFINE Topical Cream is manufactured by Bausch Health Americas Incorporated.
What is the FDA product code for BIAFINE Topical Cream?
The FDA product code for BIAFINE Topical Cream is FRO. This falls under the Anesthesiology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.